Abstract: The study was carried out to evaluate the safety of Tiandongtanggan powder through the acute toxicity test on mice and subchronic toxicity test in rats.In the acute toxicity test, pre-test (5 000, 1 000, 200, 40 mg/(kg·BW)), formal test (5 000, 2 500, 1 250, 625 mg/(kg·BW)) and maximum dose test (60 g/(kg·BW)) were performed respectively.After administration, the mental state and death of mice were observed for 7 consecutive days, the mice were dissected after the experiment.In the subchronic toxicity test, 80 Wistar rats were randomly divided into 4 groups, including high dose group (10 g/(kg·BW)), middle dose group (5 g/(kg·BW)), low dose group (2.5 g/(kg·BW)) and control group.The administration was continued for 30 days, and the clinical manifestations of the rats were observed during the test.The body weight, food intake and water intake of the rats were recorded, and the weight gain rate was calculated.After 30 days of administration, the blood routine and blood biochemical indexes were detected, the organ indexes were calculated, and histopathological examination was performed on the main organs.The results showed that there was no death of mice and no visible pathological changes in the organs in the pre-test, formal test and maximum dose test of the acute toxicity test.In the subchronic toxicity test, there were no significant differences in the body weight, hematological indexes, blood biochemical indexes, organ coefficient and histopathological examination results of rats in the groups of medium and low dose of Tiandongtanggan powder compared with the control group (P>0.05).The mean erythrocyte volume (MCV) and alanine aminotransferase (ALT) content of male rats in high-dose group were significantly higher than those in male control group (P<0.05).The red blood cell count (RBC), red blood cell distribution width (RDW) and percentage of MONO nuclear cells (MONO%) were significantly lower than those of male control group (P<0.05), but within the normal range, and the pathological tissue blood test results had no significant difference(P>0.05), indicating that 10 g/(kg·BW) Tiandongtanggan powder had certain effects on the hematological indexes and liver and kidney functions of the tested rats.The results showed that LD₅₀>5 000 mg/(kg·BW) of Tiandongtanggan powder in mice.The above results showed that Tiandongtanggan powder in the range of 10 g/(kg·BW) administered intragastrically to rats for 30 days had no obvious toxic and side effects on rats, showing good safety.

Key words: Tiandongtanggan powder; toxicological test; security